MAUDE Adverse Event Report: ABBOTT GMBH MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 03P6822

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = sample id (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed a falsely elevated magnesium result for one patient on an architect c8000 analyzer.The following data was provided (customer¿s reference range is 1.5-2.3 mg/dl): sample id (b)(6) initial result was 6.2, repeats were 1.8 and 1.8 mg/dl, when repeating on an architect c4000 the result was 1.7 mg/dl.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a falsely elevated architect magnesium result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the increased result for the product.Return testing was not completed as returns were not available.Data provided by the customer showed that the sample was retested on the complaint instrument, and on a different instrument, with normal results that were similar between the instruments.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency for the architect magnesium, lot number 87180un21, was identified.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 11987237
• MDR Text Key: 255986712
• Report Number: 3002809144-2021-00375
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740161620
• UDI-Public: 00380740161620
• Combination Product (y/n): N
• PMA/PMN Number: K181748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 03P6822
• Device Catalogue Number: 03P68-22
• Device Lot Number: 87180UN21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C803137.; ARC C8 PROC MOD, 01G06-11, C803137.